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Study 2: Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

Phase 2
18 Years
70 Years
Not Enrolling
Tobacco Dependence

Thank you

Trial Information

Study 2: Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

Smokers (N=150) will be enrolled in the study and will smoke ad libitum for a period of two
weeks during which time they will be assessed for baseline measurements. Subjects will then
be randomly assigned to one of the three conditions (N=50). Subjects will be blinded as to
whether they are assigned to the Quest nicotine-free vs. extra low nicotine condition. There
are no distinguishing features between these two cigarettes. Nicotine lozenge assignment is
open label. Subjects will be asked to use only their assigned study product (low nicotine,
nicotine-free cigarettes or lozenge) for a period of 6 weeks. Study cigarettes will be given
to them at each clinic visit and subjects will be told to smoke ad libitum. They will be
provided a supply equivalent to 150% of their baseline-smoking rate to allow for
compensatory smoking to occur. They will keep record of each cigarette they smoked. If
they smoked cigarettes other than those assigned to them, they will be asked to notate on a
sheet when that cigarette was smoked. At the end of the 6-week period, they will be asked to
quit smoking and NRT.

First morning urine and fasting blood samples will be collected at baseline and 2 and 6
weeks on the study products; at 6 weeks of abstinence and the 1 month follow-up.

Counseling. In each condition, subjects will be provided brief, structured counseling that
is similar in duration. The subjects in the cigarette conditions will discuss any
difficulties they experienced with switching cigarettes and problem solving these obstacles.
Problem solving each obstacle will be solicited from the subject. However, if no solution
or limited solution is provided, the counselor will provide a standardized response for each
of the obstacles confronted.

Follow-up Phase. Subjects will be followed up 1 month after the end of the 6 week
abstinence period.

Inclusion Criteria:

- smoking between 10-40 cigarettes daily for the past year;

- in good physical health (no unstable medical condition;

- no contraindications for medicinal nicotine;

- stable, good mental health

Exclusion Criteria:

- unwilling to use study products for 6 weeks;

- unstable medical or psychiatric condition.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Biomarkers for tobacco exposure measures: Carbon monoxide, cotinine, NNAL-gluc, NNN, mercapturic acids, 1-hydroxypytrene and biomarkers for cardiovascular risk: WBC, lipid profile, fibrinogen, heart rate, blood pressure.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Dorohty Hatsukami, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Federal Government

Study ID:

DA 013333



Start Date:

March 2005

Completion Date:

November 2006

Related Keywords:

  • Tobacco Dependence
  • Smoking
  • Harm reduction
  • Biomarkers of tobacco exposure
  • Compensatory smoking
  • Tobacco Use Disorder



Univerisity of Minnesota Minneapolis, Minnesota  55414